Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

Site IRB

Jacksonville, Florida: 17-005613

Sponsor Protocol Number: 17-005613

About this study

The purpose of this study is to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

18 years or older diagnosed with active ulcerative colitis (UC) (with a Mayo score ≥4, with an endoscopic Mayo Clinic score ≥1, and disease that extended 15 cm or more from the anal verge) who had failed with mesalamine therapy

Patients who were previously exposed to mesalamine or steroids will have a 30-day washout period before being enrolled

Patients who were previously exposed to tumor necrosis factor (TNF) antagonists will have a 60-day washout period before being enrolled

For patients who were previously exposed to glucocorticoids, immunosuppressive medications (i.e., azathioprine, 6-mercaptopurine, or methotrexate), or TNF antagonists, a documentation of unsuccessful previous treatment (i.e., lack of response or unacceptable adverse events) is required

A diagnosis of ulcerative colitis (UC) confirmed by biopsy obtained at the index colonoscopy or flexible sigmoidoscopy

Exclusion Criteria:

Patients who have been on semi-vegetarian diet before the trial will be excluded.

Other criteria include:

Pregnancy or lactation

An unstable or uncontrolled medical disorder

An anticipated requirement for major surgery

History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch

Koch pouch, or ileostomy for UC

Planned bowel surgery

Unable to give informed consent

Unable to swallow pills/capsules

Current diagnosis of fulminant colitis or toxic megacolon

Abdominal abscess

Symptomatic colonic stricture

Stoma

Disease limited to the rectum (ulcerative proctitis)

Current total parenteral nutrition

Positive Clostridium difficile stool assay

History of an infection requiring intravenous antimicrobial therapy within 1 month or oral antimicrobial therapy within 2 weeks

History of listeria

Histoplasmosis

Chronic or active hepatitis B or C infection

Human immunodeficiency virus

Immunodeficiency syndrome

Untreated tuberculosis

History of central nervous system demyelinating disease

History of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix

Evidence of dysplasia or malignancy on the screening colonoscopy/flexible sigmoidoscopy with biopsy

Reprint Permissions

A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research.